Detecting Syncope by an Integrated Multisensor Patch-type Recorder
- Conditions
- Syncope, Vasovagal
- Interventions
- Device: BP monitoring during tilt testing
- Registration Number
- NCT05782699
- Lead Sponsor
- Istituto Auxologico Italiano
- Brief Summary
The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.
- Detailed Description
Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min).
The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.
Method The study is a prospective intrapatient comparison between BP measured by mean of a cuffless patch BP monitor (RootiRX System, Rooti Labs Ltd., Taipei, Taiwan) and by mean of the standard method during tilt testing.
Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the RootiRX device and will be compared with the standard of reference. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Consecutive patients,
- >18 years of age,
- referred for tilt testing because affected by suspected reflex syncope
- Incapability to perform tilt testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patch monitoring BP monitoring during tilt testing - standard BP monitoring BP monitoring during tilt testing -
- Primary Outcome Measures
Name Time Method BP pattern 2 hours Difference between baseline (rest) BP and BP at the (pre)syncopal event ("Delta BP slope") during tilt testing with RootiRx and with standard method
- Secondary Outcome Measures
Name Time Method BP drop 2 hours Absolute BP values during tilt event with RootiRx and with Finometer
Trial Locations
- Locations (1)
IRCCS Istituto Auxologico Italiano
🇮🇹Milan, MI, Italy